Search Results for “Sanofi” – Page 9 – media

Lexicon to face FDA AdComm for Zynquista approval in diabetes and CKD

It looks like Lexicon Pharmaceuticals’ second bid to get US Food and Drug Administration (FDA) approval for Zynquista (sotagliflozin) will be as arduous as the first go around, as the regulatory agency has convened an advisory committee (AdComm) to evaluate its efficacy. The FDA’s Endocrinologic and Metabolic Drugs AdComm will discuss the benefit/risk profile of Zynquista as an adjunct to insulin therapy for glycaemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The AdComm is set to meet on 31 October 2024. Lexicon added that convening of the AdComm will not affect the Prescription Drug User Fee Act (PDUFA) goal date of 20 December 2024 set by the FDA. An AdComm is convened upon request of the FDA to review and evaluate the safety and efficacy data of a therapy. However, the AdComm recommendations are non-binding, with the final decision made by the FDA. The ...
- Source: drugdu
- 80
- August 26, 2024
Biotech Startup AIRNA Adds $60M to Advance RNA-Editing Therapy for Rare Protein Deficiency

AIRNA’s therapy for alpha1 antitrypsin deficiency, or AATD, edits RNA to address the underlying cause of this rare inherited disease. Wave Life Sciences and Korro Bio are both further along in the development of RNA-editing therapies for AATD, but AIRNA claims its therapy could be best in class. By Frank VinluanA particular protein deficiency that leads to liver and lung damage is currently treatable only with decades-old therapies that all have limitations. Biotech startup AIRNA is part of a field of companies developing novel treatments for this inherited disorder, and it aims to stand apart with a genetic medicine it contends could become best in class. AIRNA is preparing to advance this program to clinical testing and on Wednesday it revealed a fresh round of $60 million to support its plans. The disease that Cambridge, Massachusetts-based AIRNA aims to treat is alpha-1 antitrypsin deficiency, or AATD. This rare disease, affecting ...
- Source: drugdu
- 66
- August 3, 2024
Prioritised investments from pharma companies shaping competitive pipeline landscape of bronchiectasis

Recent studies have allowed the unexplored field of bronchiectasis to be further investigated by shedding light on the mechanisms behind the disease’s pathophysiology. In recent years, bronchiectasis has garnered a significant amount of attention, with pharmaceutical companies prioritising their investments in the development of promising pipeline agents to treat the disease through various mechanisms of action (MOAs). Pharmaceutical companies involved in the field of bronchiectasis include Insmed, Boehringer Ingelheim, Sanofi, Renovion, Armata Pharmaceuticals, Chiesi, CSL, BioAegis Therapeutics, and Reistone Biopharma, all of which are shaping the competitive landscape of the field, according to GlobalData. Current research focuses on disease mechanisms, such as inflammation, further uncovering potential targets for pharmaceutical companies. Such targets include neutrophil-mediated inflammation components but also general inflammation components, such as interleukins and bacteriophages. Interestingly, the pipeline landscape is filled with Phase I and Phase II agents, with only Insmed’s brensocatib in Phase III. These pipeline agents have ...
- Source: drugdu
- 91
- July 15, 2024
NICE recommends Ebglyss for atopic dermatitis patients

England’s National Institute for Health and Care Excellence (Nice) has recommended Almirall’s Ebglyss (lebrikizumab) for patients with moderate to severe atopic dermatitis, giving NHS patients another biological therapy option. In line with NICE guidelines, the NHS will now have 90 days to make the treatment available to patients. Patients over 12 years of age who have not responded to or are not able to take systemic immunosuppressants will be eligible for the therapy, as per a 10 July press release. Monoclonal antibody Ebgylss will join Sanofi / Regeneron’s Dupixent (dupilumab) and Leo Pharma’s Adbry (tralokinumab) as interleukin-targeting options for treating the skin condition. The Janus kinase (JAK) inhibitors Cibinqo (abrocitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib) developed by Pfizer, Eli Lilly, and AbbVie, respectively, are also recommended by NICE. Atopic dermatitis, also known as atopic eczema, is an inflammatory skin condition characterised by intense itching. It has an estimated prevalence of ...
- Source: drugdu
- 63
- July 12, 2024
CDC’s Advisory Committee Unanimously Recommends Vaxelis to Prevent Invasive Hemophilus Influenzae Type B in American Indian and Alaska Native Infants

Don Tracy, Associate EditorThe inclusion of Vaxelis in the CDC’s preferential recommendations is expected to influence vaccine administration strategies and public health policies in high-risk populations moving forward. Haemophilus influenzae bacteria, 3D illustration. Image Credit: Adobe Stock Images/Dr_Microbe Image Credit: Adobe Stock Images/Dr_Microbe The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has unanimously voted to add Vaxelis to its preferential recommendations for the treatment of American Indian and Alaska Native infants with invasive Hemophilus influenzae type B (Hib). Developed as a collaboration between Merck and Sanofi, Vaxelis is the only hexavalent combination vaccine available in the United States. Vaxelis could potentially offer the advantage of reducing the number of injections needed in the first year of life compared to other vaccine schedules. Moving forward, the recommendation has the potential to significantly influence vaccine administration strategies and public health policies, especially in high-risk populations.1 “We ...
- Source: drugdu
- 87
- July 2, 2024
Sarclisa Combination Improves Progression-Free Survival in Patients with Newly Diagnosed Transplant-Ineligible Multiple Myeloma

Don Tracy, Associate Editor Reportedly, data from the IMROZ study marks the first time an anti-CD38 monoclonal antibody combined with standard-of-care therapy has demonstrated significant improvement in progression-free survival for newly diagnosed transplant-ineligible multiple myeloma. Results from the IMROZ Phase III trial show that Sanofi’s Sarclisa (isatuximab-irfc) in combination with standard-of-care therapy comprised of lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death by 40% compared to a solo VRd regimen in patients with newly diagnosed transplant-ineligible multiple myeloma (MM). According to the company, the data represents the first time an anti-CD38 monoclonal antibody combined with VRdsupported a significant improvement in progression-free survival (PFS) for these patients. “The significant progression-free survival (PFS) benefit observed with Sarclisa combination therapy compared to VRd is important and encouraging for patients with newly diagnosed multiple myeloma. Effective frontline therapy has the potential to modify the course of the disease, which ...
- Source: drugdu
- 69
- July 1, 2024
Verona scores FDA approval for Ohtuvayre as COPD maintenance therapy

The US Food and Drug Administration (FDA) has approved Verona Pharma’s Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is an inhaled dual inhibitor of phosphodiesterase 3 and phosphodiesterase 4 enzymes and has bronchodilator and non-steroidal anti-inflammatory effects. Verona plans to launch the therapy in Q3 this year. “With substantial funding of up to $650m secured, Verona Pharma is well-positioned to distribute Ohtuvayre in the US, ensuring its availability even beyond 2026,” said Asiyah Nawab, Pharma Analyst at GlobalData. The Ohtuvayre approval was based on the positive results from Phase III ENHANCE-1 and ENHANCE-2 trials (NCT04535986 and NCT04542057). The data from the pooled analysis of the studies showed significant improvements in the symptoms of COPD exacerbations, including dyspnea, breathlessness, cough, sputum, and chest symptoms, in patients with moderate to severe COPD. Ohtuvayre is expected to generate global sales of $1.1bn by 2029, ...
- Source: drugdu
- 89
- June 29, 2024
Lilly joins fellow pharma giants in OpenAI partnership

Eli Lilly has joined a growing list of pharma companies to partner with OpenAI, as it seeks to develop new treatments for drug-resistant pathogens. The collaboration will utilise the generative artificial intelligence (genAI) from OpenAI to come up with new solutions for microbial infections. Lilly didn’t specify the exact details of how OpenAI’s technology will be used, or any financial terms of the deal. Lilly joins Sanofi and Moderna, who have both unveiled partnerships with the genAI platform OpenAI this year. Last month, Sanofi announced that it was partnering with Formation Bio and OpenAI to harness AI to expedite drug development. On the other hand, Moderna has incorporated ChatGPT into an internal messaging platform called mChat, to harness data analytics, and use image generation, and dose selection. This new collaboration with OpenAI builds on Lilly’s commitment to tackle antimicrobial resistance (AMR). The pharma giant previously contributed $100m to the AMR ...
- Source: drugdu
- 110
- June 28, 2024
Avidity Bio’s RNA Therapy Flashes Early Signs of Treating a Muscular Dystrophy’s Root Cause

Avidity Biosciences’ RNA therapy for facioscapulohumeral muscular dystrophy has preliminary clinical data showing it knocked down expression of a gene that causes this rare disease. More details will be presented at a medical conference this week. By Frank VinluanAn experimental RNA therapy from Avidity Biosciences has early clinical trial results showing it reduced by half the expression of a gene at the root of a rare, inherited form of muscular dystrophy with no FDA-approved therapies. Furthermore, patients in the study are showing signs of regaining muscle function. Based on these initial results announced Wednesday, Avidity said it plans to accelerate the start of additional cohorts in the Phase 1/2 study that could support an application seeking regulatory approval in this disease, facioscapulohumeral muscular dystrophy (FSHD). More details about the data are coming soon. Avidity plans to present the preliminary results during the Annual FSHD Society International Research Congress meeting, which ...
- Source: drugdu
- 78
- June 14, 2024
Skye Bioscience Falls Short in Glaucoma Trial, But It’s Full Steam Ahead for Obesity Program

Skye Bioscience’s nimacimab blocks CB1, the same receptor targeted by an obesity drug candidate now in the hands of Novo Nordisk. But Skye contends its Phase 2-ready antibody drug has several advantages over the small molecule that joined Novo’s pipeline in a deal valued at $1 billion. By Frank VinluanDespite some evidence that cannabis reduces intraocular eye pressure from glaucoma, the ophthalmology community hasn’t embraced its use. One reason cited: The short duration of effect means a patient must smoke or ingest a lot of marijuana to maintain its effect throughout the day. Skye Bioscience’s ambitions to bring glaucoma patients these therapeutic benefits in a twice-daily eye drop have missed the mark. The clinical-stage company is now turning its focus to another drug that targets the same receptor in a different way for a different indication — weight loss. In doing so, Skye aims to show it can compete with ...
- Source: drugdu
- 83
- June 12, 2024

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